Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-28 @ 9:32 AM
Study NCT ID:
NCT01905267
Status:
COMPLETED
Last Update Posted:
2018-07-30
First Post:
2013-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mindfulness Intervention to Study the Neurobiology of Depression
Sponsor:
Organization:
Raw JSON
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Mindfulness is a key component of this intervention as a strategy for disengaging from one's thoughts. Strategies from Dialectical Behavior Therapy (DBT), such as the use of effective interpersonal skills, are also included as methods for regulating strong emotion. Rumination-Focused Cognitive Behavior Therapy is a structured, manual based program designed to be delivered weekly over eight weeks. Sessions are 60-90 minutes in length.", 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'seriousEvents': [{'term': 'Suicidality', 'notes': 'Five participants were hospitalized for suicidality or suicidal gestures.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Change in Children's Depression Rating Scale - Revised", 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': "Participants randomized to the experimental condition will receive 8 weeks of individual treatment with Rumination-Focused Cognitive Behavior Therapy\n\nRumination-Focused Cognitive Behavior Therapy: This intervention targets rumination and other maladaptive forms of emotion regulation such as suppression and avoidance and provides skills training in effective coping strategies. Mindfulness is a key component of this intervention as a strategy for disengaging from one's thoughts. Strategies from Dialectical Behavior Therapy (DBT), such as the use of effective interpersonal skills, are also included as methods for regulating strong emotion. Rumination-Focused Cognitive Behavior Therapy is a structured, manual based program designed to be delivered weekly over eight weeks. 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Range is between 17-119 Higher scores mean higher depressive symptoms', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'completers sample'}, {'type': 'SECONDARY', 'title': 'Change in Reynolds Adolescent Depression Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': "Participants randomized to the experimental condition will receive 8 weeks of individual treatment with Rumination-Focused Cognitive Behavior Therapy\n\nRumination-Focused Cognitive Behavior Therapy: This intervention targets rumination and other maladaptive forms of emotion regulation such as suppression and avoidance and provides skills training in effective coping strategies. Mindfulness is a key component of this intervention as a strategy for disengaging from one's thoughts. Strategies from Dialectical Behavior Therapy (DBT), such as the use of effective interpersonal skills, are also included as methods for regulating strong emotion. Rumination-Focused Cognitive Behavior Therapy is a structured, manual based program designed to be delivered weekly over eight weeks. Sessions are 60-90 minutes in length."}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '64.41', 'spread': '12.12', 'groupId': 'OG000'}, {'value': '63.50', 'spread': '12.42', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '56.93', 'spread': '13.22', 'groupId': 'OG000'}, {'value': '61.5', 'spread': '13.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 week', 'description': 'Self report adolescent depression total score. Range is 30-120 with higher scores meaning greater depressive symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '8 week completers sample'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': "Participants randomized to the experimental condition will receive 8 weeks of individual treatment with Rumination-Focused Cognitive Behavior Therapy\n\nRumination-Focused Cognitive Behavior Therapy: This intervention targets rumination and other maladaptive forms of emotion regulation such as suppression and avoidance and provides skills training in effective coping strategies. Mindfulness is a key component of this intervention as a strategy for disengaging from one's thoughts. Strategies from Dialectical Behavior Therapy (DBT), such as the use of effective interpersonal skills, are also included as methods for regulating strong emotion. Rumination-Focused Cognitive Behavior Therapy is a structured, manual based program designed to be delivered weekly over eight weeks. 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Mindfulness is a key component of this intervention as a strategy for disengaging from one's thoughts. Strategies from Dialectical Behavior Therapy (DBT), such as the use of effective interpersonal skills, are also included as methods for regulating strong emotion. Rumination-Focused Cognitive Behavior Therapy is a structured, manual based program designed to be delivered weekly over eight weeks. 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Range is between 17-119 Higher scores mean higher depressive symptoms'}], 'secondaryOutcomes': [{'measure': 'Change in Reynolds Adolescent Depression Scale', 'timeFrame': 'Baseline, 8 week', 'description': 'Self report adolescent depression total score. Range is 30-120 with higher scores meaning greater depressive symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mindfulness', 'relapse prevention', 'recovery', 'depression', 'adolescents'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '32555582', 'type': 'DERIVED', 'citation': 'Bessette KL, Jacobs RH, Heleniak C, Peters AT, Welsh RC, Watkins ER, Langenecker SA. Malleability of rumination: An exploratory model of CBT-based plasticity and long-term reduced risk for depressive relapse among youth from a pilot randomized clinical trial. PLoS One. 2020 Jun 17;15(6):e0233539. doi: 10.1371/journal.pone.0233539. eCollection 2020.'}, {'pmid': '27880789', 'type': 'DERIVED', 'citation': 'Jacobs RH, Watkins ER, Peters AT, Feldhaus CG, Barba A, Carbray J, Langenecker SA. Targeting Ruminative Thinking in Adolescents at Risk for Depressive Relapse: Rumination-Focused Cognitive Behavior Therapy in a Pilot Randomized Controlled Trial with Resting State fMRI. PLoS One. 2016 Nov 23;11(11):e0163952. doi: 10.1371/journal.pone.0163952. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'The Pediatric Mood Disorders Program at the University of Illinois at Chicago is conducting a research study examining how mindfulness can help teenagers stay healthy and prevent depression relapse.', 'detailedDescription': 'Study involves:\n\n* Brain scan using fMRI technology\n* Questions about mood and behavior\n* Meeting with a clinician\n* Possibility of 8 weekly treatment sessions using mindfulness\n* Ongoing assessment of depression for next 2 years\n\nEligible participants will be compensated for their time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between the ages of 12 and 18\n* history of major depressive disorder\n\nExclusion Criteria:\n\n* braces\n* afraid of small spaces'}, 'identificationModule': {'nctId': 'NCT01905267', 'acronym': 'MIND', 'briefTitle': 'Mindfulness Intervention to Study the Neurobiology of Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Mindfulness Intervention to Study the Neurobiology of Depression', 'orgStudyIdInfo': {'id': '2012-0689'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Participants randomized to the experimental condition will receive 8 weeks of individual treatment with Rumination-Focused Cognitive Behavior Therapy', 'interventionNames': ['Behavioral: Rumination-Focused Cognitive Behavior Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study'}], 'interventions': [{'name': 'Rumination-Focused Cognitive Behavior Therapy', 'type': 'BEHAVIORAL', 'description': "This intervention targets rumination and other maladaptive forms of emotion regulation such as suppression and avoidance and provides skills training in effective coping strategies. Mindfulness is a key component of this intervention as a strategy for disengaging from one's thoughts. Strategies from Dialectical Behavior Therapy (DBT), such as the use of effective interpersonal skills, are also included as methods for regulating strong emotion. Rumination-Focused Cognitive Behavior Therapy is a structured, manual based program designed to be delivered weekly over eight weeks. Sessions are 60-90 minutes in length.", 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60608', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago Pediatric Mood Disorders Program', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Rachel H Jacobs, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor, Licensed Clinical Psychologist', 'investigatorFullName': 'Rachel Jacobs', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}